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E-Book/E-Doc

Title Guidance for industry [electronic resource] : quality systems approach to pharmaceutical CGMP regulations.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:Q 1/2    ---  Available
Description 1 online resource (28 p.)
Note "Center for Biologics Evaluation and Research (CBER)."
"Center for Veterinary Medicine (CVM)."
"Office of Regulatory Affairs (ORA)."
"Pharmaceutical CGMPs."
"September 2006."
Bibliography Includes bibliographical references (p. 25-26).
Subject Quality of products -- United States.
Drug development -- Government policy -- United States.
Risk management -- United States.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
United States. Food and Drug Administration. Office of Regulatory Affairs.
Added Title Quality systems approach to pharmaceutical CGMP regulations
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:Q 1/2

 
    
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